Delveinsight

DECEMBER 29, 2020

Audentes Therapeutics’ ASPIRO Trial Free to Proceed. The Food and Drug Administration (FDA) decided to lift the clinical ban from Audentes Therapeutics’ ASPIRO trial, which was aimed at investigating its AT132 for the treatment of X-linked myotubular myopathy (XLMTM), a rare neuromuscular disease. . The post A USD 4.2

Trials 52

Trials Drugs Hormones Radiology 52

FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

Clinical Trials 59

Clinical Trials Clinical Trials Insulin Radiology 59

pharmaphorum

JUNE 18, 2021

The Compliant Component Builder platform has already been put through its paces at AstraZeneca, which used it to build a new component to incorporate into one of its existing digital health tools, used for remote monitoring of patients in clinical trials. The algorithms used in healthcare are becoming more complex as well.

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Production Regulation Manufacturing Packaging 98

Delveinsight

DECEMBER 10, 2020

The full data from late-phase trials of AstraZeneca’s COVID-19 vaccine have pointed to the potential for AZD1222 to work after a single dose and limit asymptomatic cases; however, missed main questions regarding the efficacy of the candidate. In a pooled analysis of 11,636 participants enrolled in two separate clinical trials in the U.K.

Gene Therapy 52

Gene Therapy Gene Vaccination Vaccine 52

XTalks

JUNE 12, 2023

Medtronic’s proactive stance towards R&D is evident from the over 230 clinical trials it conducted and the more than 200 regulatory approvals it received in the US, Europe, Japan and China in the 2022 fiscal year. Internationally, Medtronic expanded its MiniMed 780G insulin pump and Guardian 4 sensor.

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FDA Approval Production Sales In-Vitro 98

Worldwide Clinical Trials

JANUARY 24, 2025

Metabolic dysfunction-associated steatohepatitis (MASH) presents a complex challenge in clinical trials due to its multifaceted nature and requirements for proper diagnosis. At Worldwide Clinical Trials, were committed to leveraging our MASH experience and patient-centric approach to navigate these challenges and drive better outcomes.

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Clinical Trials Clinical Trials Trials Radiology 130